Study of Viramidine to Ribavirin in Patients With Chronic Hepatitis C Who Are Treatment-Naive

Bausch Health

Status and phase

Completed

Phase 3

Conditions

Chronic Hepatitis C

Treatments

Drug: Viramidine

Drug: Ribavirin

Drug: pegylated interferon alfa-2b

Study type

Interventional

Funder types

Industry

Identifiers

NCT00230958

RNA003142-301

Details and patient eligibility

About

This purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before recieved treatment.

Full description

Compare the efficacy and safety of viramidine 600 mg BID versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2b to treatment-naive patients with chronic hepatitis C (CHC)

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Treatment-naive patients with compensated chronic hepatitis C.
HCV RNA >2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL).

Exclusion criteria

Severe neuropsychiatric disorders
History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, opthalmologic disorders including severe retinopathy, or immune mediated disease
Pregnant or breast-feeding patients